News Briefs: Clinical Practice Updates
By News Staff
This roundup includes the following brief clinical practice updates:
FDA Approves Expanded Indication for Boostrix
The FDA has approved a request by drugmaker GlaxoSmithKline to supplement its biologics license application for Boostrix, the manufacturer's tetanus, diphtheria and acellular petussis, or Tdap, vaccine. The vaccine, which in 2005 had been approved as a single booster dose for people ages 10-18 years, now also is approved as a booster for adults ages 19-64.
Sanofi pasteur's Tdap vaccine, Adacel, also was licensed in 2005 for use as a booster in patients ages 11-64 years. At that time, it was the only vaccine licensed as a pertussis booster in adults.
The CDC's Advisory Committee on Immunization Practices, or ACIP, subsequently voted to recommend routine use of Tdap, rather than tetanus and diphtheria toxoids vaccine, as a booster dose in adults ages 19-64 who had not previously received Tdap.
More information on Boostrix is available online (20-page PDF; About PDFs).
Sanofi pasteur's Tdap vaccine, Adacel, also was licensed in 2005 for use as a booster in patients ages 11-64 years. At that time, it was the only vaccine licensed as a pertussis booster in adults.
The CDC's Advisory Committee on Immunization Practices, or ACIP, subsequently voted to recommend routine use of Tdap, rather than tetanus and diphtheria toxoids vaccine, as a booster dose in adults ages 19-64 who had not previously received Tdap.
More information on Boostrix is available online (20-page PDF; About PDFs).
FDA Requires Suicidality Warning on Antiepileptic Drugs
The FDA is requiring manufacturers of antiepileptic drugs to update their product labeling to include a warning that the drugs increase the risk of suicidal thoughts and behaviors. The action includes all antiepileptic drugs, including those used to treat psychiatric disorders, migraine headaches and other conditions, as well as epilepsy.
The FDA issued a public health advisory and an information alert to physicians in December 2008, noting that physicians should notify patients taking these drugs, as well as their families and caregivers, about the increased suicidality risk.
The agency based its action on a review of 199 clinical trials involving 11 antiepileptic drugs. The review showed that patients receiving antiepileptic drugs had almost twice the risk of suicidal behavior or thoughts compared with patients who received a placebo.
More information, including a list of antiepileptic drugs required to add warnings about the risk of suicidality, is available online.
The FDA issued a public health advisory and an information alert to physicians in December 2008, noting that physicians should notify patients taking these drugs, as well as their families and caregivers, about the increased suicidality risk.
The agency based its action on a review of 199 clinical trials involving 11 antiepileptic drugs. The review showed that patients receiving antiepileptic drugs had almost twice the risk of suicidal behavior or thoughts compared with patients who received a placebo.
More information, including a list of antiepileptic drugs required to add warnings about the risk of suicidality, is available online.
Combination Vaccine Deemed Safe, Effective
A recent study (abstract) in the journal Pediatrics concludes that the combination vaccine Pentacel is a suitable replacement for separately administered diphtheria, tetanus and acellular pertussis; inactivated poliovirus; and Haemophilus influenzae type b vaccines.
Pentacel, manufactured by Toronto-based sanofi pasteur, was first licensed in Canada in 1997 and is commonly used there. In this trial, conducted to support U.S. licensure of the vaccine in June 2008, researchers conclude that the vaccine is safe and effective.
In addition, reducing the total number of injections given during a child's first 18 months by seven may improve adherence and optimize protection by simplifying an increasingly complex schedule of immunizations, say the researchers.
Pentacel, manufactured by Toronto-based sanofi pasteur, was first licensed in Canada in 1997 and is commonly used there. In this trial, conducted to support U.S. licensure of the vaccine in June 2008, researchers conclude that the vaccine is safe and effective.
In addition, reducing the total number of injections given during a child's first 18 months by seven may improve adherence and optimize protection by simplifying an increasingly complex schedule of immunizations, say the researchers.
Research Centers Launch Web Site
The Educational Consortium of the Centers for Education and Research on Therapeutics, or CERTS, a federally funded network of 14 research centers, has joined with the Agency for Healthcare Research and Quality and the FDA in launching a Web site to provide information to health care professionals, patients, family members and medical faculty.
Clinician-Consumer Health Advisory Information Network offers emerging data about the safety and effectiveness of drugs, devices and biological products approved by the FDA, as well as access to educational and informational resources developed through CERTs research and educational initiatives.
Clinician-Consumer Health Advisory Information Network offers emerging data about the safety and effectiveness of drugs, devices and biological products approved by the FDA, as well as access to educational and informational resources developed through CERTs research and educational initiatives.
